Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-03

Study Completion Date

2022-12-04

Brief Summary

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Dexmedetomidine is recommended over fentanyl as adjunctive medication to bupivacaine for saddle block spinal anesthesia in anal surgeries and procedures.

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Detailed Description

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Objectives: A saddle spinal block is a viable choice for anal surgeries. This technique effectively maintains balanced hemodynamics, and fast recovery, and prevents irrelevant motor blocks in both limbs.

Methods: Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml). Continuous monitoring of HR and SpO2 was conducted. Evaluation of sensory blockage and the motor block was done utilizing the Bromage scale. Following surgery, assessments were conducted. Pain in the ward and PACU was determined utilizing the visual analog scale (VAS).

Conditions

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Regional Anesthesia Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

The subjects were randomly categorized into two groups utilizing random numbers generated by computer software. A sealed envelope (containing the allocation numbers of groups) was opened at the time of patient enrollment.

Study Groups

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The FENT Group

Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).

Group Type OTHER

FENT group

Intervention Type DRUG

Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).

The DEX Group

The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).

Group Type OTHER

DEX group

Intervention Type DRUG

The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).

Interventions

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FENT group

Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).

Intervention Type DRUG

DEX group

The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).

Intervention Type DRUG

Other Intervention Names

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fentanyl group dexmedetomidine group

Eligibility Criteria

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Inclusion Criteria

* both sexes
* aged between 20 and 60
* classified as II \& ASA-I
* scheduled for elective anal surgeries

Exclusion Criteria

* subjects who refused to participate
* uncontrolled hypertension
* BMI \> 30 kg/m2
* heart failure (class IV or III) based on the New York Heart Association (NYHA)
* uncorrected coagulopathy
* any study's drug allergy
* drug abuse
* neuropathy
* any spinal anesthesia contraindication (such as infection or a pelvic fracture)

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes